BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION EXTRA GLUCOMETERS

    MDR report key: 1944108 · Received December 27, 2010

    Report

    Report Number
    MW5018743
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 24, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ABBOTT
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REGARDING PRECISION EXTRA TEST STRIP MALFUNCTIONS. I HAVE BEEN USING THESE DAILY AS OUR GLUCOMETERS. I NOTICED THAT IF THERE ISN'T ENOUGH BLOOD DURING FIRST ATTEMPT TO OBTAIN FINGER STICK A FALSE READING WILL OCCUR. USUALLY LOW. OUR NURSING HOME OBTAINED NEW TEST STRIPS ON THE DAY OF THE RECALL. THE NEXT DAY, I HAD A PT WITH A LOW GLUCOSE READING OF 38 WITH CLINICAL SYMPTOMS. I RETESTED PT. FROM SAME BLOOD SOURCE A SECOND TIME AND OBTAINED A READING OF 181. KNOWING THIS PT AND HER CLINICAL SYMPTOMS I RETESTED AGAIN AND OBTAINED A READING OF 46. I TREATED THE PT; WAS TREATED FOR THE HYPOGLYCEMIC RXN. I HAD NOTICED THAT THERE WERE PROBLEMS WITH LOW READINGS FOR SOME TIME. THOUGHT IT WAS THE AGE OF EQUIPMENT OR A LOW BATTERY. I STILL BELIEVE THERE ARE PROBLEMS WITH THE PRECISION EXTRA GLUCOMETERS AND SHOULD BE FURTHER INVESTIGATED. I AM A REGISTERED NURSE IN (B)(6). PRECISION EXTRA GLUCOMETERS AND TEST STRIPS WITH NEW APPROVED LOT#'S CONTINUE TO HAVE UNRELIABLE AND OR FALSE READINGS. DATES OF USE: (B)(6) 2009 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DIABETES GLUCOSE. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION EXTRA GLUCOMETERS GLUCOMETER NBW ABBOTT UNK NEW STRIPS
    2 PRECISION EXTRA TEST STRIPS TEST STRIPS NBW ABBOTT W/APP LOT #'S

    Patients

    Seq Age Sex Outcome Treatment
    1